Wednesday, August 30, 2017

The Dual Images of Stem Cell Medicine Highlighted in the Headlines

Google news stem cell headlines this week
A couple of notable headlines surfaced this week dealing with stem cell matters, capturing something of the dichotomy in a field that has been heralded for its possible production of miracle cures. 

One story told of a person who plays football for a living, Doug Baldwin, who is known as the $46 million man.  He decided to spend some time in England this summer receiving what he believes was a stem cell treatment to prevent his knees from deteriorating. It was the type of story that gives many others hope that some sort of stem cell therapy could cure a serious or fatal condition despite the fact that no such cure has been approved for widespread use in this country. 

The other story told of a modest crackdown by the Food and Drug Administration (FDA) on a couple of unregulated stem cell clinics in this country, a move that many believe was long overdue. More than 500 such clinics exist in the United States.  One of the California clinics identified by the FDA was using a restricted small pox vaccine as part of its treatment. 

Your average health care consumer could justifiably wonder, "What in the world is going on? Is this stuff safe or what?" Some scientists have been long frustrated by the dueling public faces of stem cell medicine. On one hand, stories of miracle cures involving professional athletes generate great attention and tend to create faith in the efficacy of stem cell treatments, although the therapies involved do not measure up to scientific standards. On the other hand, the FDA is now taking a more active role in policing dubious actors in this business.

Our average medical consumer might believe that the FDA action signals a new assurance of stem cell safety or is it the other way around? Is the stem cell glass half full or half empty?

Paul Knoepfler, a stem cell researcher at UC Davis, has been the bellwether for seven years regarding news about unregulated and dubious stem cell clinics. He once even went sort of undercover to attend a public marketing session produced by one clinic in the Sacramento area. 

Knoepfler wrote this week on his blog about the FDA action, its implications and the questions that remain. He said the FDA action was a "very big deal." 

But Knoepfler said six important questions remain:
  • "How much further will the FDA go with actual enforcement actions?
  • "Will the FDA define fat stem cells as a drug (or not) in upcoming guidances?
  • "How will the FDA handle non-homologous use of bone marrow cells in the commercial sector?
  • "Will the FDA work to deal with the growing problem of unapproved, amniotic stem cell offerings? 
  • "What about networks of stem cell businesses?
  • "Will other entities like state medical boards use this FDA action as a spring-board to get off the sidelines and take positive action too?"
Meantime, patients will continue to have to wade through conflicting claims, hype and the possibility of serious medical harm or death as they ponder whether they should undergo a stem cell treatment. 
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